1.In order to avoid animal testing, testing on vertebrate animals for the
purposes of this Regulation shall be undertaken only as a last resort. It
is also necessary to take measures limiting duplication of other tests.

2.The sharing and joint submission of information in accordance with this
Regulation shall concern technical data and in particular information related
to the intrinsic properties of substances. Registrants shall refrain
from exchanging information concerning their market behaviour, in particular as
regards production capacities, production or sales volumes, import volumes or
market shares.

3.If the same substance has previously been registered less than 12 years
earlier, the Agency shall inform the potential registrant without delay of the
names and addresses of the previous registrant(s) and of the relevant summaries
or robust study summaries, as the case may be, already submitted by them.

(a)shall, in the case of information
involving tests on vertebrate animals; and

(b)may, in the case of information not
involving tests on vertebrate animals,

request from the previous registrant(s) the
information he requires with respect to Article 10(a)(vi) and (vii) in order
to register.

2.When a request for information has been made according to paragraph 1,
the potential and the previous registrant(s) as referred to in paragraph 1 shall
make every effort to reach an agreement on the sharing of the information
requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by
submission of the matter to an arbitration board and acceptance of the
arbitration order.

3.The previous registrant and
potential registrant(s) shall make every effort to ensure that the costs of
sharing the information are determined in a fair, transparent and
non-discriminatory way. This may be facilitated by following cost sharing
guidance based on those principles which is adopted by the Agency in accordance
with Article 77(2)(g). Registrants are only required
to share in the costs of information that they are required to submit to
satisfy their registration requirements.

4.On agreement on the sharing of the information, the previous registrant shall make available to the new registrant the agreed information and shall
give the new registrant the permission to refer to the previous registrant's
full study report.

6.Within one month from the receipt
of the information referred to in paragraph 5, the Agency shall give the
potential registrant permission to refer to the information requested by him in
his registration dossier, subject to the potential registrant providing, upon
request by the Agency, proof that he has paid the previous registrant(s) for
that information a share of cost incurred. The previous registrant(s) shall
have a claim on the potential registrant for a proportionate share of the cost
incurred by him. Calculation of the proportionate share may be facilitated by
the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the full study report available to
the potential registrant, the previous registrant(s) shall have a claim on the
potential registrant for an equal share of the cost incurred by him, which
shall be enforceable in the national courts.

7.An appeal may be brought, in
accordance with Articles 91, 92 and 93, against Agency decisions under
paragraph 6 of this Article.

1.In order to benefit from the transitional regime provided for in Article
23 each potential registrant of a phase-in substance in quantities of 1 tonne
or more per year, including without limitation intermediates, shall submit all
the following information to the Agency:

(a)the name of the substance as
specified in Section 2 of Annex VI, including its EINECS and CAS number or, if
not available, any other identity codes;

(b)his name and address and the name
of the contact person and, where appropriate, the name and address of the
person representing him in accordance with Article 4 as specified in Section 1
of Annex VI;

(d)the name(s) of substance(s) as
specified in Section 2 of Annex VI, including their EINECS and CAS number or,
if not available, any other identity codes, for which the available information
is relevant for the application of Sections 1.3 and 1.5 of Annex XI.

2.The information referred to in paragraph 1 shall be submitted within a
time period starting on 1 June 2008 and ending on 1
December 2008.

3.Registrants who do not submit the
information required under paragraph 1 shall not be able to rely on Article 23.

4.The Agency shall by 1 January 2009 publish on its website a list of
the substances referred to in paragraph 1(a) and (d). That list shall
comprise only the names of the substances, including their EINECS and CAS
number if available and other identity codes, and the first envisaged
registration deadline.

6.Potential registrants who
manufacture or import for the first time a phase-in substance in quantities of one
tonne or more per year or use for the first time a phase-in substance in the
context of production of articles or import for the first time an article containing a phase-in substance that would require registration, after 1 December
2008, shall be entitled to rely on Article 23 provided that they submit the
information referred to in paragraph 1 of this Article to the Agency within six
months of first manufacturing, importing or using the substance in quantities
of one tonne or more per year and no later than 12 months before the relevant
deadline in Article 23.

(a)facilitate, for the purposes of
registration, the exchange of the information specified in Article 10(a) (vi)
and (vii) between potential registrants, thereby avoiding the duplication of
studies; and

3.SIEF participants shall provide
other participants with existing studies, react to requests by other
participants for information, collectively identify needs for further studies
for the purposes of paragraph 2(a) and arrange for such studies to be carried
out. Each SIEF shall be operational until 1 June 2018.

Article 30
Sharing of data involving tests

1.Before testing is carried out in order to meet the information
requirements for the purposes of registration, a SIEF participant shall inquire
whether a relevant study is available by communicating within his SIEF. If
a relevant study involving tests on vertebrate animals is available within the
SIEF, a participant of that SIEF shall request that study. If a relevant study
not involving tests on vertebrate animals is available within the SIEF, a SIEF participant may request that study.

Within one month of the request, the owner of
the study shall provide proof of its cost to the participant(s) requesting it. The
participant(s) and the owner shall make every effort to ensure that the costs
of sharing the information are determined in a fair, transparent and non
discriminatory way. This may be facilitated by following any cost sharing
guidance which is based on those principles and is adopted by the Agency in
accordance with Article 77(2)(g). If they cannot reach
such an agreement, the cost shall be shared equally. The owner shall give
permission to refer to the full study report for the purpose of registration
within two weeks of receipt of payment. Registrants are only required to share
in the costs of information that they are required to submit to satisfy their
registration requirements.

2.If a relevant study involving tests is not available within the SIEF,
only one study shall be conducted per information requirement within each SIEF by one of its participants acting on behalf of the others. They shall take all
reasonable steps to reach an agreement within a deadline set by the Agency as
to who is to carry out the test on behalf of the other participants and to
submit a summary or robust study summary to the Agency. If no agreement is
reached, the Agency shall specify which registrant or downstream user shall
perform the test. All participants of the SIEF who require a study shall
contribute to the costs for the elaboration of the study with a share
corresponding to the number of participating potential registrants. Those
participants that do not carry out the study themselves shall have the right to
receive the full study report within two weeks following payment to the
participant that carried out the study.

3.If the owner of a study as referred to in paragraph 1 which involves
testing on vertebrate animals refuses to provide either proof of the cost of
that study or the study itself to (an)other participant(s), he shall not be
able to proceed with registration until he provides the information to the
other participants(s). The other participant(s) shall proceed with registration without fulfilling the relevant information requirement, explaining the reason
for this in the registration dossier. The study shall not be repeated unless
within 12 months of the date of registration of the other participant(s), the
owner of this information has not provided it to them and the Agency decides
that the test should be repeated by them. However, if a registration containing
this information has already been submitted by another registrant, the Agencyshall give the other participant(s) permission to refer to the information in
his registration dossier(s). The other registrant shall have a claim on the
other participant(s) for an equal share of the cost, provided he makes the full
study report available to the other participant(s), which shall be enforceable
in the national courts.

4.If the owner of a study as referred to in paragraph 1 which does not
involve testing on vertebrate animals refuses to provide either proof of the
cost of that study or the study itself to (an)other participant(s), the other
SIEF participants shall proceed with registration as if no relevant study was
available in the SIEF.

5.An appeal may be brought, in accordance with Articles 91, 92 and 93,
against Agency decisions under paragraphs 2 or 3 of this Article.

6.The owner of the study who has refused to provide either proof of the
cost or the study itself, as referred to in paragraph 3 or 4 of this Article,
shall be penalised in accordance with Article 126.